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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00980512
Other study ID # R01MH060195
Secondary ID R01MH0601952R01M
Status Completed
Phase N/A
First received September 18, 2009
Last updated November 17, 2014
Start date September 2009
Est. completion date July 2014

Study information

Verified date November 2014
Source San Diego State University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The primary goal of this study is to examine the fidelity and generalization of parenting effects of the KEEP foster parent training intervention as it is being delivered within a child welfare system of care by a community mental health provider.


Description:

The primary goal of this study is to utilize this opportunity as a real-world platform for addressing three key questions that need to be answered prior to wide-scale implementation of the KEEP intervention. First, do the effects of the KEEP parent training generalize (concurrently) to other children currently in foster and kin intervention homes and lead to reductions in overall levels of behavior problems? Second, does the KEEP intervention continue to have effects after the completion of the intervention and generalize (temporally) to new children who enter the homes of these families at a later point in time? Finally, as the KEEP intervention is being implemented by a community agency in a real-world system of care, can the intervention be delivered and maintained in a manner that preserves the goals and quality of the intervention?

Children in foster care, between the ages of 5 and 12, will be randomly assigned to one of two conditions - the KEEP intervention or a "services as usual" condition. In the KEEP intervention condition, foster and kin caregivers will participate in 16 weekly group meetings. Outcomes to be assessed include child problem behavior (of the focal child and other children in the household), child functioning, parental stress, family functioning, use of mental health services, child placement changes (e.g., reunification with biological parents, move to another foster home), and foster parent retention rates. In addition, for a year following the completion of the intervention, new children entering the home of foster/kin caregiver will be included in the assessments, along with the impact of these additional children on parental stress and family functioning. Finally, several dimensions of intervention fidelity (e.g., facilitator adherence and group engagement) will be assessed and examined in relation to child, family, and system outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 354
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- Any child between ages 5 and 12 in relative or non-relative foster care

Exclusion Criteria:

- Only medically fragile children

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Parent Training
16 weeks of parent training led by trained group facilitator

Locations

Country Name City State
United States Child and Adolescent Services Research Center San Diego California

Sponsors (3)

Lead Sponsor Collaborator
San Diego State University National Institute of Mental Health (NIMH), Oregon Social Learning Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chamberlain P, Price J, Leve LD, Laurent H, Landsverk JA, Reid JB. Prevention of behavior problems for children in foster care: outcomes and mediation effects. Prev Sci. 2008 Mar;9(1):17-27. doi: 10.1007/s11121-007-0080-7. Epub 2008 Jan 10. — View Citation

Chamberlain P, Price J, Reid J, Landsverk J. Cascading implementation of a foster and kinship parent intervention. Child Welfare. 2008;87(5):27-48. — View Citation

Price JM, Chamberlain P, Landsverk J, Reid JB, Leve LD, Laurent H. Effects of a foster parent training intervention on placement changes of children in foster care. Child Maltreat. 2008 Feb;13(1):64-75. doi: 10.1177/1077559507310612. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in child behavior problems as assessed by the Parent Daily Report (PDR) Baseline, 6-months, 12-months, 18-months No
Secondary Placement Disruptions from Foster Placement 6-month, 12-month, 18-month No
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